Galectin Therapeutics Receives US Patent for Potential Ground-Breaking Treatment for Fatty Liver Disease

Galectin Therapeutics Receives US Patent for Potential Ground-Breaking
Treatment for Fatty Liver Disease

NORCROSS, Ga., Sept. 10, 2013 (GLOBE NEWSWIRE) -- Galectin Therapeutics
(Nasdaq:GALT), the leading developer of therapeutics that target galectin
proteins to treat fibrosis and cancer, today announced that it has received a
notice of issuance from the U.S. Patent and Trademark Office for Patent
Application Number 13/573,454 titled "Galacto-rhamnogalacturonate compositions
for the treatment of non-alcoholic steatohepatitis and non-alcoholic fatty
liver disease." The patent covers the Company's carbohydrate-based galectin
inhibitor compound GR-MD-02 for use in patients with fatty liver disease with
or without fibrosis or cirrhosis. Fatty liver disease affects as many as 15
million Americans, results in severe scarring of the liver (cirrhosis), and
there are no currently approved pharmaceutical therapies.

The U.S. Food and Drug Administration (FDA) recently granted GR-MD-02 Fast
Track designation for non-alcoholic steatohepatitis (NASH) with hepatic
fibrosis, commonly known as fatty liver disease with advanced fibrosis.
Galectin Therapeutics is currently conducting a Phase 1 clinical trial to
evaluate the safety, tolerability and exploratory biomarkers for efficacy for
single and multiple doses of GR-MD-02 over four weekly doses of GR-MD-02
treatment in patients with fatty liver disease with advanced fibrosis.

"The issuance of this patent provides broad coverage in the U.S. for the use
of GR-MD-02 in fatty liver disease through September 2031 and international
patent coverage is pending for the same intellectual property," said Peter G.
Traber, MD, President, CEO and CMO of Galectin Therapeutics. "There is a truly
vast unmet medical need for the treatment of fatty liver disease with
fibrosis, as the most prevalent liver disease in the U.S. We are hopeful that
our development program for GR-MD-02 will lead to the first therapy for this
unmet medical need."

The patent inventors include Peter Traber, Eliezer Zomer and Anatole Klyosov
with assignment to Galectin Therapeutics. The major claims are for methods of
obtaining galectin inhibitor compounds, obtaining a composition for parenteral
or enteral administration in an acceptable pharmaceutical carrier and
administering to a subject having at least one of the following: fatty liver,
non-alcoholic fatty liver disease, non-alcoholic steatohepatitis,
non-alcoholic hepatitis with liver fibrosis, non-alcoholic steatohepatitis
with cirrhosis, or non-alcoholic steatohepatitis with cirrhosis and
hepatocellular carcinoma. The use covers reversing or slowing the progression
of disease activity or medical consequences of the disease. Moreover,
additional claims cover the use of the galectin inhibitor compounds in
combination with multiple other agents that may have potential activity in the
disease that are under investigation elsewhere.

About Fatty Liver Disease with Advanced Fibrosis

Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has
become a common disease of the liver with the rise in obesity rates, estimated
to affect nine to 15 million people, including children, in the U.S. Fatty
liver disease is characterized by the presence of fat in the liver along with
inflammation and damage in people who drink little or no alcohol. Over time,
patients with fatty liver disease can develop fibrosis, or scarring of the
liver, and it is estimated that as many as three million individuals will
develop cirrhosis, a severe liver disease where liver transplantation is the
only current treatment available. Approximately 6,300 liver transplants are
done on an annual basis in the U.S. There are no drug therapies approved for
the treatment of liver fibrosis. FDA and AASLD (American Association for the
Study of Liver Disease) recently held a 2-day workshop with leading scientific
experts in NASH and key FDA officials to discuss acceptable regulatory
endpoints for approval of drugs to treat NASH

About Galectin Therapeutics

Galectin Therapeutics (Nasdaq:GALT) is developing promising carbohydrate-based
therapies for the treatment of fibrotic liver disease and cancer based on the
Company's unique understanding of galectin proteins, key mediators of biologic
function. We are leveraging extensive scientific and development expertise as
well as established relationships with external sources to achieve cost
effective and efficient development. We are pursuing a clear development
pathway to clinical enhancement and commercialization for our lead compounds
in liver fibrosis and cancer. Additional information is available at

Forward Looking Statements

This press release contains, in addition to historical information,
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements relate to future events or
future financial performance, and use words such as "may," "estimate,"
"could," "expect" and others. They are based on our current expectations and
are subject to factors and uncertainties which could cause actual results to
differ materially from those described in the statements. These statements
include those regarding the hope that our development program for GR-MD-02
will lead to the first therapy for the treatment of fatty liver disease with
fibrosis. Factors that could cause our actual performance to differ materially
from those discussed in the forward-looking statements include, among others,
that we may not be successful in developing effective treatments and/or
obtaining the requisite approvals for the use of GR-MD-02 or any of our other
drugs in development. Our current clinical trial and any future clinical
studies may not produce positive results in a timely fashion, if at all, and
could prove time consuming and costly. Plans regarding development, approval
and marketing of any of our drugs are subject to change at any time based on
the changing needs of our company as determined by management and regulatory
agencies. Regardless of the results of any of our development programs, we may
be unsuccessful in developing partnerships with other companies that would
allow us to further develop and/or fund any studies or trials.To date, we
have incurred operating losses since our inception, and our ability to
successfully develop and market drugs may be impacted by our ability to manage
costs and finance our continuing operations For a discussion of additional
factors impacting our business, see our Annual Report on Form 10-K for the
year ended December 31, 2012, and our subsequent filings with the SEC. You
should not place undue reliance on forward-looking statements. Although
subsequent events may cause our views to change, we disclaim any obligation to
update forward-looking statements.

CONTACT: Galectin Therapeutics Inc.
         Peter G. Traber, MD, 678-620-3186
         President, CEO, & CMO

Galectin Therapeutics, Inc. Logo
Press spacebar to pause and continue. Press esc to stop.